CN112763622B - Method for determining plamavir through liquid chromatography - Google Patents
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- CN112763622B CN112763622B CN202011605192.0A CN202011605192A CN112763622B CN 112763622 B CN112763622 B CN 112763622B CN 202011605192 A CN202011605192 A CN 202011605192A CN 112763622 B CN112763622 B CN 112763622B
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Abstract
The invention discloses a method for determining plavavir by liquid chromatography, which comprises the following steps: s1: preparing a standard solution; s2: preparing a sample solution: weighing Favipiravir preparation, raw material medicine, intermediate or intermediate reaction liquid, and adding diluent to prepare solution with 0.1mg/mL of Favipiravir Wei Nongdu as sample solution; s3: sample injection analysis: injecting 20 μ L of each of the blank solution, the standard solution and the sample solution into a liquid chromatograph for determination, wherein the column temperature is 35 ℃, and the flow rate is 1.0mL/min; s4: recording the peak area, and calculating the content of the Pilatvir according to an external standard method. The method has the advantages of simple and convenient operation steps, good reproducibility, high sensitivity and accurate detection result, can effectively guide the quality of research and development production departments, and can also make the quality departments have basis for centering control and releasing finished product detection.
Description
Technical Field
The invention belongs to the technical field of Favipiravir detection, and particularly relates to a method for determining Piperavir through liquid chromatography.
Background
Favipiravir, developed by Fushan chemical from Fuji film of Japan, was approved for sale in Japan 3 months 2014 for antiviral treatment of influenza A and B. Research shows that the medicine has good antiviral effect on various RNA viruses except influenza virus, such as Ebola virus, arenavirus, bunyavirus, rabies virus and the like. The novel coronavirus belongs to coronavirus, is a positive strand single stranded RNA virus with an overcoat membrane, and the Favipiravir also has potential antiviral effect on the novel coronavirus from the mechanism. In the year 2020, 3, 17, the introduction of Zhang Xinmin, which is the department of science and technology, biological center, favipiravir has completed clinical research and shows good clinical efficacy for treating 2019-nCoV. Based on the fact that various raw materials are inevitably used in the chemical synthesis process, other byproducts except the target product can be generated, and the final product can be degraded in the storage and preparation processes, the liquid chromatography determination method of the piravir bulk drug and the intermediate can well control the quality of the product, including the content, inherent impurities containing the intermediate, degradation products and the like.
Disclosure of Invention
The invention aims to provide a method for determining plausivir by liquid chromatography, which solves the problems in the background technology.
In order to achieve the purpose, the invention provides the following technical scheme: a method for determining plavavir through liquid chromatography comprises the following steps in sequence:
s1: preparing a standard solution: adding a diluent into a proper amount of Favipira Wei Chengpin or an intermediate standard substance to prepare a solution with 0.1mg/mL of Favipira Wei Nongdu as a standard substance solution;
s2: preparing a sample solution: weighing Favipiravir preparation, raw material medicine, intermediate or intermediate reaction liquid, and adding diluent to prepare solution with 0.1mg/mL of Favipiravir Wei Nongdu as sample solution;
s3: and (3) sample injection analysis: balancing the instrument with initial conditions, after balancing the base line, injecting 20 mu L of blank solution, standard solution and sample solution into a liquid chromatograph for determination, wherein the column temperature is 35 ℃, and the flow rate is 1.0mL/min;
s4: recording the peak area, calculating the content of the Pilatvir according to an external standard method,
the content of Favipiravir in Favipira Wei Yangpin is calculated according to the following formula:
the liquid chromatography detection conditions are set to adopt gradient elution conditions, and are as follows:
| time/min | Mobile phase A% | Mobile phase B% |
| 0 | 80 | 20 |
| 15 | 50 | 50 |
| 16 | 80 | 20 |
| 20 | 80 | 20 |
。
Preferably, the mobile phase A adopted by the liquid chromatograph is an acidic aqueous solution added with an ion pair reagent, the pH value is 1-3, the optimal composition of the mobile phase A is 1mL/L phosphoric acid added with 1g/L sodium octane sulfonate, the operation is simple and convenient, and the error is controllable.
Preferably, the acidic aqueous solution is one of phosphoric acid, trifluoroacetic acid and perchloric acid.
Preferably, the ion pair reagent is one of sodium heptanesulfonate, sodium octane sulfonate, sodium nonane sulfonate, sodium decane sulfonate and sodium perchlorate, and the concentration is 5-25mmol/L.
Preferably, the mobile phase B adopted by the liquid chromatograph is 90% acetonitrile water solution.
Preferably, the liquid chromatograph comprises a high performance liquid chromatograph comprising an ultraviolet detector and an octadecyl bonded silica gel chromatographic column, and the ultraviolet detector is an ultraviolet full wavelength scanning detector (DAD 222 nm).
The invention preferably comprises the determination of purity, the determination method is the same in the process of purity determination, and the difference is as follows:
the sample solution was prepared as follows: taking a proper amount of Favipiravir preparation, raw material medicine, intermediate or intermediate reaction liquid, adding diluent to prepare a solution with the concentration of a target substance of about 0.5mg/mL as a sample solution,
The invention has the technical effects and advantages that: 1. the method has the advantages of simple and convenient operation steps, good reproducibility, high sensitivity and accurate detection result, can effectively guide the quality of research and development production departments, and can also make the quality departments have basis for centering control and finished product detection;
2. the method is suitable for the whole production cycle of the Favipira Wei Yanfa, is suitable for detection of central control, release of intermediates and finished products in the production process of the Favipira Wei Yanfa, is also suitable for detection of various formulations of related Favipiravir preparations, such as content, related substances, dissolution and the like, effectively guides the production process, and is simple and convenient to operate and accurate in result;
3. the instruments, detectors, chromatographic columns and reagent consumables used by the invention are all popular and easily available, and the operability and stability of different laboratories are high.
Drawings
FIG. 1 is a sample spectrum for purity measurement according to the present invention;
FIG. 2 is a 1% self-control profile of the purity test of the present invention;
FIG. 3 is a quantitative limit graph of impurities with retention time of 8.7min according to the present invention;
FIG. 4 is a graph of the linear range of impurities according to the present invention;
FIG. 5 is a sample profile for content detection according to the present invention;
FIG. 6 is a graph of the degree of separation of impurities according to the present invention.
Detailed Description
The following will clearly and completely describe the technical solutions in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
A method for determining plavavir through liquid chromatography comprises the following steps in sequence:
s1: preparing a standard solution: adding a diluent into a proper amount of Favipira Wei Chengpin or an intermediate standard substance to prepare a solution with 0.1mg/mL of Favipira Wei Nongdu as a standard substance solution;
s2: preparing a sample solution: weighing Favipiravir preparation, raw material medicine, intermediate or intermediate reaction liquid, and adding diluent to prepare solution with 0.1mg/mL of Favipiravir Wei Nongdu as sample solution;
s3: sample injection analysis: balancing the instrument with initial conditions, after balancing the base line, injecting 20 mu L of blank solution, standard solution and sample solution into a liquid chromatograph for determination, wherein the column temperature is 35 ℃, and the flow rate is 1.0mL/min;
s4: recording the peak area, calculating the content of the Pilatvir according to an external standard method,
the content of Favipiravir in Favipira Wei Yangpin is calculated according to the following formula:
the liquid chromatography detection conditions are set to adopt gradient elution conditions, and are as follows:
| time/min | Mobile phase A% | Mobile phase B% |
| 0 | 80 | 20 |
| 15 | 50 | 50 |
| 16 | 80 | 20 |
| 20 | 80 | 20 |
。
Specifically, the mobile phase A adopted by the liquid chromatograph is an acidic aqueous solution added with an ion pair reagent, the pH value is 1-3, the optimal composition of the mobile phase A is 1mL/L phosphoric acid added with 1g/L sodium octane sulfonate, the operation is simple and convenient, and the error is controllable.
Specifically, the acidic aqueous solution is one of phosphoric acid, trifluoroacetic acid and perchloric acid.
Specifically, the ion pair reagent is one of sodium heptanesulfonate, sodium octane sulfonate, sodium nonanesulfonate, sodium decanesulfonate and sodium perchlorate, and the concentration is 5-25mmol/L.
Specifically, the mobile phase B adopted by the liquid chromatograph is 90% acetonitrile water solution.
Specifically, the liquid chromatograph comprises a high performance liquid chromatograph containing an ultraviolet detector and an octadecyl bonded silica gel chromatographic column, wherein the ultraviolet detector is an ultraviolet full-wavelength scanning detector (DAD 222 nm).
The invention preferably comprises the determination of purity, the determination method is the same in the process of purity determination, and the difference is as follows:
the sample solution was prepared as follows: taking a proper amount of Favipiravir preparation, raw material medicine, intermediate or intermediate reaction liquid, adding diluent to prepare a solution with the concentration of a target substance of about 0.5mg/mL as a sample solution,
Example 1:
1. searching for chromatographic condition
The instrument comprises the following steps: agilent 1260 (quaternary single pump), full wavelength scanning (DAD), evaporative Light Scattering (ELSD), electrospray (CAD) and other detectors are adopted as detectors, and the DAD detector is finally selected, wherein the optimal wavelength is 222nm.
A chromatographic column: an improved octadecyl bonded silica gel developed by Agilent company is used as a fixed phase, and the type is as follows: SB-Aq, 250X 4.6mm, particle size 3 μm.
The mobile phase is an acidic aqueous solution added with an ion pair reagent (mobile phase A) -acetonitrile solution (mobile phase B) as a mobile phase, wherein the acid reagent applied to the mobile phase A is phosphoric acid, trifluoroacetic acid, perchloric acid and the like, the pH value of the mobile phase A is adjusted to be 1-3, the ion pair reagent is sodium heptane sulfonate, sodium octane sulfonate, sodium nonane sulfonate, sodium decane sulfonate, sodium perchlorate and the like, the concentration is 5-25mmol/L, and the optimal composition of the mobile phase A is 1mL/L phosphoric acid added with 1g/L sodium octane sulfonate; mobile phase B was 90% acetonitrile in water.
The column temperature was 35 ℃, the flow rate was 1.0mL/min, and the sample size was 20. Mu.L. Gradient elution procedure is as follows:
| time/min | Mobile phase A% | Mobile |
| 0 | 80 | 20 |
| 15 | 50 | 50 |
| 16 | 80 | 20 |
| 20 | 80 | 20 |
2. System applicability
The Favipira Wei Zhufeng obtained by the method and impurity peaks can be effectively separated, and the separation degree R is larger than 1.5; the peak shape of the main peak is good, and the number of theoretical plates is more than 2000; the minimum concentration detected by the method P Wei Zazhi is 0.05%, the signal-to-noise ratio is more than or equal to 3, the series of concentration samples accord with a linear relation through testing, and the correlation coefficient is 0.998; the same sample solution is subjected to sample injection analysis once every one hour, so that the impurity spectrum is not changed within 24 hours, the impurity content is not obviously changed, and the RSD of the main peak area is less than 2%.
The applicability test of the system can prove that: the method for detecting the plavavir and the intermediate has the advantages of stability, reliability, good reproducibility, sensitive and accurate result and capability of effectively controlling the product quality.
3. Sample solution detection
When the purity is detected, a proper amount of the Favipiravir bulk drug and the intermediate or the intermediate reaction solution is taken, and the diluent is added to prepare a solution of about 0.5mg/mL of the target substance as a sample solution.
In the content detection, a proper amount of Favipiravir bulk drug and intermediate standard substance is precisely weighed, and a diluent is added to prepare a solution of about 0.1mg/mL of a target substance as a standard substance solution. Precisely weighing a proper amount of Favipiravir bulk drug and intermediate or intermediate reaction liquid, and adding diluent to prepare a solution of about 0.1mg/mL of a target substance as a sample solution.
Sample injection analysis: and (3) balancing an instrument by using initial conditions, after balancing by using a base line, respectively injecting 20 mu L of blank solution and sample solution, recording sample solution maps with blank peaks subtracted, and calculating the purity or impurity content by using a corrected area normalization method or calculating the content of a target substance by using an external standard method.
Example 2: examination of related substances of Favipiravir intermediate
1. Chromatographic conditions
The instrument comprises the following steps: agilent 1260 (quaternary single pump), DAD detector, optimal wavelength 222nm. A chromatographic column: agilent SB-Aq, 250X 4.6mm, particle size 3 μm. The mobile phase is an acidic aqueous solution added with an ion pair reagent (mobile phase A) -acetonitrile solution (mobile phase B) and is optimally composed of 1mL/L phosphoric acid and 1g/L sodium octane sulfonate; mobile phase B was 90% acetonitrile in water. The column temperature was 35 ℃, the flow rate was 1.0mL/min, and the sample size was 20. Mu.L. Gradient elution procedure is as follows:
| time/min | Mobile phase A% | Mobile |
| 0 | 80 | 20 |
| 15 | 50 | 50 |
| 16 | 80 | 20 |
| 20 | 80 | 20 |
2. Sample solution detection
Taking a proper amount of the Favipiravir intermediate, and adding a diluent to prepare a solution with the concentration of about 0.5mg/mL as a sample solution. An appropriate amount of the solution was removed and diluted 100-fold with a diluent to prepare a solution of about 0.005mg/mL as a control solution (1.0%). The instrument was balanced according to the chromatographic conditions described above, and 20. Mu.L of blank solution, control solution, and sample solution were injected after the baseline was stabilized. If there is an impurity peak in the sample solution, the area of the single impurity peak should not exceed the area of the control solution peak (1.0%), and the sum of all impurity peaks should not exceed twice the area of the control solution peak (2.0%).
Example 3: favipiravir bulk drug or Favipiravir tablet related substance examination
1. Chromatographic conditions
The instrument comprises the following steps: agilent 1260 (quaternary single pump), DAD detector, optimal wavelength 222nm. A chromatographic column: agilent SB-Aq, 250X 4.6mm, particle size 3 μm. The mobile phase is an acidic aqueous solution added with an ion pair reagent (mobile phase A) -acetonitrile solution (mobile phase B) and is optimally composed of 1mL/L phosphoric acid and 1g/L sodium octane sulfonate; mobile phase B was 90% acetonitrile in water. The column temperature was 35 ℃, the flow rate was 1.0mL/min, and the sample size was 20. Mu.L. Gradient elution procedure is as follows:
2. sample solution detection
Taking a proper amount of Favipiravir bulk drug, and adding a diluent to prepare a solution containing about 0.5mg Favipiravir per 1mL as a sample solution. Or taking 20 Favipiravir tablets, precisely weighing, grinding, precisely weighing a proper amount of diluent, and preparing a solution containing about 0.5mg Favipiravir per 1mL as a sample solution. The instrument was balanced according to the chromatographic conditions, and 20 μ L of blank solution and sample solution were injected after the baseline was stabilized. And recording the sample solution spectrum with the blank peak subtracted, and calculating the content of the related substances by using a corrected area normalization method.
Example 4: content inspection of favipiravir bulk drug or favipiravir tablet
1. Chromatographic conditions
The instrument comprises the following steps: agilent 1260 (quaternary single pump), DAD detector, optimal wavelength 222nm. And (3) chromatographic column: agilent SB-Aq, 250X 4.6mm, particle size 3 μm. The mobile phase is an acidic aqueous solution added with an ion pair reagent (mobile phase A) -acetonitrile solution (mobile phase B) and is optimally composed of 1mL/L phosphoric acid and 1g/L sodium octane sulfonate; mobile phase B was 90% acetonitrile in water. The column temperature was 35 ℃, the flow rate was 1.0mL/min, and the sample size was 20. Mu.L. Gradient elution procedure is as follows:
| time/min | Mobile phase A% | Mobile |
| 0 | 80 | 20 |
| 15 | 50 | 50 |
| 16 | 80 | 20 |
| 20 | 80 | 20 |
2. Sample solution detection
Taking a proper amount of Favipira Wei Biaozhun products, adding a diluent to prepare a solution containing about 0.1mg Favipiravir per 1mL as a standard solution. Taking a proper amount of Favipiravir bulk drug, adding diluent to prepare a solution containing 0.1mg Favipiravir per 1mL as a sample solution. Or taking 20 Favipiravir tablets, precisely weighing, grinding, precisely weighing a proper amount of diluent, and preparing a solution containing about 0.1mg Favipiravir per 1mL as a sample solution. The instrument was balanced according to the chromatographic conditions, and 20 μ L of blank solution, standard solution, and sample solution were injected after the baseline was stabilized. And recording standard solution and sample solution maps with blank peak deduction, and calculating the content of the Favipiravir bulk drug or Favipiravir tablets by an external standard method.
Although the present invention has been described with reference to a preferred embodiment, it should be understood that various changes, substitutions and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims.
Claims (1)
1. A method for measuring plaavir by liquid chromatography is characterized by comprising the following steps: the method comprises the following steps in sequence:
s1: preparing a standard solution: adding a proper amount of a Fapida Wei Chengpin or an intermediate standard substance into a diluent to prepare a solution with 0.1mg/mL of Fapida Wei Nongdu as a standard substance solution;
s2: preparing a sample solution: weighing Favipiravir preparation, raw material medicine, intermediate or intermediate control reaction liquid, and adding diluent to prepare solution of 0.1mg/mL Favipiravir Wei Nongdu as sample solution;
s3: sample injection analysis: injecting 20 μ L of each of the blank solution, the standard solution and the sample solution into a liquid chromatograph for determination, wherein the column temperature is 35 ℃, and the flow rate is 1.0mL/min;
s4: recording the peak area, calculating the content of the Pilatvir according to an external standard method,
the content of Favipiravir in Favipira Wei Yangpin is calculated according to the following formula:
the liquid chromatography detection conditions were set to adopt gradient elution conditions as follows:
；
The mobile phase A adopted by the liquid chromatograph is an acidic aqueous solution added with an ion pair reagent, and the pH value is 1-3;
the acidic aqueous solution is one of phosphoric acid, trifluoroacetic acid and perchloric acid;
the ion pair reagent is one of sodium heptanesulfonate, sodium octane sulfonate, sodium nonane sulfonate, sodium decane sulfonate and sodium perchlorate;
the mobile phase B adopted by the liquid chromatograph is 90% acetonitrile water solution;
the liquid chromatograph comprises a high performance liquid chromatograph containing an ultraviolet detector and an octadecyl bonded silica gel chromatographic column.
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